Medical Device Submissions Guidebook: 510(k) & De Novo
This in-depth 510(k) & De Novo Guidebook will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed®’s Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
State of the Nation 2025: Global Medical Device Recall Index Report
Download Sedgwick’s Global Medical Device Recall Report for key insights on compliance, regulations, and global recall trends. Members only.
AdvaMed® Congratulates Dr. Makary on his Confirmation as FDA Commissioner
Washington, D.C.– AdvaMed, The Medtech Association®, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Marty Makary to serve as commissioner of…
The Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield™ blood test for colorectal cancer (CRC)…
MedTech Reimbursement Playbook
Learn the basic principles of how medical technologies are covered and paid by insurers and the challenges medtech companies face.
Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
PFAS in Medtech
Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…
AdvaMed® Anticipates EtO Sterilization Rule, Voices Concern About Impact on Patient Care
By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in…